Adjustable convex ostomy device

ABSTRACT

Certain embodiments of the present application relate to an adjustable ostomy wafer system including an ostomy wafer and an insert ring 100. The ostomy wafer includes an adjustable layer with an effluent opening through which effluent flows, and the adjustable layer has a body-facing side and a non-body-facing side. The insert ring 100 is capable of providing or increasing convexity of the adjustable layer when the insert ring 100 is pressed against the non-body-facing side of the adjustable layer.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. Provisional PatentApplication No. 62/802,631, filed 7 Feb. 2019, the contents of which areincorporated by reference in their entirety.

BACKGROUND

There are many forms of ostomy care products which try to provide asecure, comfortable fit for ostomates. There remains a need, however,for ostomy products that fit and seal skin contours, including flush,retracted, prolapsed and irregular shaped stomas. For these instances,there is a need for an ostomy system that is convex in shape to create agood seal at the base of the stoma in order to prevent leakage andprotect the skin from stoma output. Current convex stoma systems,however, are complicated and difficult to customize.

SUMMARY

Current convex ostomy wafer products only offer a limited degree ofconvexity in any given device. In addition, stoma environment andtopography may change over time, both suddenly and gradually. Therefore,an ostomate may sometimes require a deep convex wafer, while a shallowconvex wafer is preferable at other times. Ideally an ostomate wouldonly have to purchase a single ostomy wafer system that would providevarying levels of convexity depending on their current need. To addressthis need, ostomy wafers that provide varying levels of convexity aredisclosed herein.

In some embodiments, disclosed herein are adjustable ostomy wafersystems, methods and devices. In some instances, the systems, methodsand devices comprise an ostomy wafer comprising an adjustable layer,with an effluent opening through which effluent flows; and an insertring capable of providing or increasing convexity of the adjustablelayer when the insert ring is pressed against the non-body-facing sideof the adjustable layer.

In some instances, the adjustable ostomy wafer systems comprise anexternal adhesive layer extending beyond an outer edge of the adjustablelayer, wherein the external adhesive layer has an adhesive body-facingside. In other embodiments, the adjustable layer holds the insert ringin place during use to maintain the convexity in the adjustable layer.In yet other instances, the insert ring comprises a groove that engagesa portion of the adjustable layer. In some instances, the groove engagesan edge of the adjustable layer located proximal to the effluentopening, thereby securing and maintaining a position of the insert ringin the adjustable layer.

In still other instances, the adjustable ostomy wafer systems, devicesand methods disclosed herein further comprise a convex insert, wherein agroove of the insert ring of the systems, devices and methods disclosedherein engages the convex insert, thereby securing and maintaining aposition of the insert ring in the adjustable layer. In some instances,at least a portion of the convex insert that engages the groove is morerigid than the adjustable layer or a portion thereof. In yet otherinstances, the adjustable ostomy wafer systems, methods and devicesdisclosed herein comprise at least one locking tab that engages thegroove of the insert ring, maintaining a position of the insert ring inthe adjustable layer. In yet other instances, the insert ring comprisesa plurality of grooves, wherein each of the grooves corresponds to adifferent level of convexity of the adjustable layer. In still otherinstances, the convexity of the adjustable layer is varied between aminimal convexity of about ⅛ inch and a maximal convexity of about 1inch. In yet other instances, the convexity of the adjustable layer isvaried between a minimal convexity of about ½ inch and a maximalconvexity of about 1 inch. In some instances, the insert ring isflexible. In other instances, the insert ring is rigid.

In some embodiments, the adjustable ostomy wafer systems, devices andmethods disclosed herein comprise an internal adhesive layer that atleast partially covers the body-facing surface of the adjustable layer.In some instances, the adjustable layer comprises an adhesive agent. Insome instances, the adjustable layer provides a barrier or seal againsteffluent, ensuring effluent flows only through the effluent opening. Insome instances, the height of the insert ring may be modulated by theuser before or during use. The adjustable ostomy wafer system of anypreceding claim, comprising a coupling component that couples the ostomywafer to an ostomy pouch.

In some instances, the coupling component of the adjustable ostomy wafersystems, devices and methods disclosed herein mechanically couples theostomy wafer to the ostomy pouch. In yet other instances, the couplingcomponent adhesively couples the ostomy wafer to the ostomy pouch. Instill other instances, the coupling component can be attached to theostomy pouch and subsequently separated without damage to the ostomypouch or the coupling component.

In some instances, disclosed herein are ostomy devices and methods, theostomy devices and methods comprising the adjustable ostomy wafersystems, devices and methods disclosed herein and an ostomy pouch. Insome embodiments, the ostomy wafer is permanently attached to the ostomypouch. In still other embodiments, the ostomy wafer and ostomy pouch areconfigured such that the effluent opening is not sealed to an ostomypouch opening until after the insert ring is pressed against thenon-body-facing side of the adjustable layer and the ostomy wafer isapplied to the stoma. In yet other instances, the ostomy wafer andostomy pouch are provided as separate pieces before use.

In still other instances, the ostomy methods, devices and systemsdisclosed herein comprise contacting a flush stoma or a retracted stomawith the ostomy wafer. In some instances, the insert ring is pressed orcapable of being pressed into the adjustable layer to provide orincrease convexity of the adjustable layer. In yet instances, the insertring is retractable or capable of being retracted from the adjustablelayer after pressing to decrease convexity.

In some embodiments, disclosed herein are kits comprising an ostomywafer comprising an adjustable layer, with an effluent opening throughwhich effluent flows; and a plurality of insert rings capable ofproviding or increasing convexity of the adjustable layer when theinsert ring is pressed against the non-body-facing side of theadjustable layer, wherein a first insert ring and a second insert ringof the plurality of insert rings differ in an aspect selected fromdiameter, rigidity, height, and a combination thereof. In someinstances, at least one insert ring comprises a groove that engages aportion of the adjustable layer. In other instances, the first insertring and the second insert ring each comprise at least one groove. Inyet other instances, the first insert ring and the second insert ringcomprise a different number of grooves.

In yet other instances, the kits disclosed herein further comprises anostomy pouch, wherein the ostomy pouch is capable of coupling to acoupling component of the ostomy wafer. In still other embodiments, theostomy pouch and the ostomy wafer are provided as separate componentsbefore use. In other embodiments, the ostomy pouch and the ostomy waferare connected before use, but the effluent opening and non-body-facingside of the ostomy wafer is exposed before use.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an embodiment of an insert ring with grooves.

FIG. 2 depicts an embodiment of an unactuated adjustable wafer from thepouch facing side of the wafer.

FIG. 3 depicts an embodiment of an adjustable wafer with minimalconvexity, viewed from the stoma facing side of the wafer.

FIG. 4 depicts an embodiment of an adjustable wafer with mediumconvexity, viewed from the stoma facing side of the wafer.

FIG. 5 depicts an embodiment of an adjustable wafer with maximalconvexity, viewed from the stoma facing side of the wafer.

FIG. 6 depicts an embodiment of a fully actuated adjustable wafer withmaximal convexity, viewed from the pouch facing side of the wafer.

FIG. 7 depicts an embodiment of an adjustable wafer, showing a side viewcross section with a convex insert than engages an insert ring.

FIG. 8 depicts an embodiment of an ostomy device including an adjustablewafer and an ostomy pouch.

FIG. 9 depicts an embodiment of a kit including a plurality of insertrings and an ostomy wafer.

DETAILED DESCRIPTION

Current convex ostomy wafer products are inadequate, affordinginflexible options for an ostomate that may require change over time. Toaddress this need, ostomy wafers that provide different levels ofconvexity are disclosed herein. Thus, the ostomy wafers disclosed hereinmay be referred to as adjustable ostomy wafers or convex adjustablewafers, due to the custom, adjustable convexity that they afford. Customconvexity is achieved with an insert ring, which is generally more rigidthan the ostomy wafer itself. Insert rings disclosed herein generallyhave a structure or feature that allows it to engage the ostomy wafer,thereby maintaining its position in the ostomy wafer. In addition toproviding user-customized convexity, the insert ring provides increasedsupport or stability at the base of the stoma relative to existingostomy wafers (without insert rings). This increased support orstability provides the benefit of a more secure fit, while thesurrounding adjustable layer in contact with the body ensures usercomfort.

Provided herein are devices, systems and kits that comprise adjustableostomy wafers. The adjustable ostomy wafers disclosed herein areaccompanied by insert rings which are used as an instrument to varyconvexity of the wafers. In some instances, adjustable ostomy wafersdisclosed herein comprise a mouldable, stretchable, or flexible layer,referred to as an adjustable layer herein. In some instances, at least aportion of the adjustable ostomy wafers disclosed herein is mouldable orcomprises a mouldable component.

In some embodiments, adjustable layers of the ostomy wafers disclosedherein have an adhesive surface on a body-facing side. In someembodiments, the adjustable layer comprises a first adhesive surface andan external layer (radially surrounding or overlapping the adjustablelayer) comprises a second adhesive surface. The first adhesive surfaceand the second adhesive surface may have different properties suitableto different regions of the stoma and surrounding skin. In someembodiments, the adjustable layer does not have an adhesive surface andthe external layer (radially surrounding or overlapping the adjustablelayer) comprises an adhesive surface on a body-facing side of theexternal layer.

Generally, the ostomy wafers disclosed herein possess no convexity or aminimum amount of convexity before use, and an increased amount ofconvexity, relative to the minimum amount, during use. The ostomy wafersdisclosed herein are designed to be adjustable to fit a variety of stomadepths, sizes, and shapes.

Provided herein are methods for using insert rings disclosed herein withexisting ostomy wafers. Further provided herein are methods formodifying existing ostomy wafers to function with insert rings disclosedherein. For example, existing moldable wafers may be modified with awafer insert that can engage the insert ring. The wafer insert may be asubstantially two-dimensional wafer insert, simply providing a rimaround the effluent opening of the wafer that is relatively more rigidthan the ostomy wafer and capable of engaging the insert ring. Thetwo-dimensional wafer insert may be desirable to a user who wants towear form-fitting clothing. Alternatively, the wafer insert may be athree-dimensional wafer insert, also referred to herein as a convexinsert. The convex insert may providing additional structure forengaging the insert ring, thereby stabilizing the insert ring in theostomy wafer and providing greater security. This may be desirable to auser who is more physically active.

Certain Terminologies

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as is commonly understood by one of skill in theart to which the claimed subject matter belongs. It is to be understoodthat the foregoing general description and the following examples areexemplary and explanatory only and are not restrictive of any subjectmatter claimed. In this application, the use of the singular includesthe plural unless specifically stated otherwise. It must be noted that,as used in the specification and the appended claims, the singular forms“a,” “an,” and “the” include plural referents unless the context clearlydictates otherwise. In this application, the use of “or” means “and/or”unless stated otherwise. Furthermore, use of the term “including” aswell as other forms, such as “include,” “includes,” and “included,” isnot limiting.

As used herein, ranges and amounts can be expressed as “about” aparticular value or range. About also includes the exact amount. Forexample, “about 5 cm” means “about 5 cm” and also “5 cm.” Generally, theterm “about” includes an amount that would be expected to be withinexperimental error. The term “about” includes values that are within 10%less to 10% greater of the value provided. For example, “about 50%”means “between 45% and 55%.” Also, by way of example, “about 30” means“between 27 and 33.”

The section headings used herein are for organizational purposes onlyand are not to be construed as limiting the subject matter described.

As used herein, the terms “individual(s),” “subject(s),” and“patient(s)” mean any mammal. In some embodiments, the mammal is ahuman. In some embodiments, the mammal is a non-human.

For the purposes of the present application, the term “stoma” refers toan opening in the body. Generally the stoma is a surgical opening in thetorso of the body. In some instances, the term “stoma” also refers tointernal tissue, organs or portions thereof that are exposed by theopening. By way of non-limiting example, internal tissue may be selectedfrom colon, ileum, small intestine, large intestine, jejunum, andduodenum, and combinations thereof. The internal tissue may be an end ora loop of a small or large intestine.

Unless specified otherwise, the term “flush/retracted skin” refers toany skin surrounding the opening, whether it be external skin orperistomal skin, or a combination thereof.

For the purposes of the present application, the term “external skin”refers to skin near the stoma, but generally not in contact withinternal tissues or effluent. As used herein, the term “peristomal skin”refers to skin in contact with internal tissues or likely to contacteffluent.

The term “effluent” refers to any internal fluids produced by anostomate that may be secreted from the stoma or that exit the stoma.

As used herein, the term “ostomate” refers to a subject that may haveuse of the ostomy wafers disclosed herein. While ostomate usually refersto a subject with a surgical opening, as used herein, “ostomate” mayrefer to a subject who has a stoma, regardless of whether the stoma wascreated by surgery or other means.

The ostomy wafers disclosed herein are described for use with agastrointestinal stoma, but could be used in other contexts as well. Theostomy wafers disclosed herein may be used for managing a stoma createdby an esophagostomy, a gastrostomy, a cholecystectomy, acholedochostomy, a cecostomy, a colostomy, a duodenostomy, an ileostomy,a jejunostomy, an appendicostomy, a tracheostomy, a urostomy, urostomy,a nephrostomy, an ureterostomy, or a vesicostomy.

As used herein, the term “wafer” may be used interchangeably with theterms “adapter,” “adjustable wafer,” “convex wafer,” “three-dimensionalmouldable adapter,” “ostomy wafer,” or “adjustable convex wafer.” Insome instances, where it is noted, the term “wafer” may refercollectively to all layers, e.g., the external layer and the adjustablelayer, of the ostomy wafer. Unless otherwise specified, these terms maybe used interchangeably.

The ostomy wafers disclosed herein may be used with additional ostomywafers including, but not limited to, a shunt, a catheter, a cap, and aplug.

Adjustable Wafer System

Provided herein are adjustable ostomy wafer systems 90 and kits thatcomprise adjustable ostomy wafers 200 and insert rings 100 disclosedherein. Certain adjustable ostomy wafers 200 disclosed herein comprisean adjustable layer 220 capable of customized convexity when the insertring 100 is pressed against the adjustable layer 220 or a regionthereof. Further provided herein are methods that comprise the use ofadjustable ostomy wafers 200 and insert rings 100 disclosed herein. Insome embodiments, insert rings 100 disclosed herein comprise at leastone groove 120 as shown in FIG. 1. The at least one groove 120 may allowthe insert ring 100 to engage the ostomy wafer 200 at varying positionsor depths of ostomy wafer convexity. In some embodiments, the ostomywafer system 90 may be provided to the ostomate in an unactuatedconformation, as seen in FIG. 2. In some instances, the insert ring 100is provided together with the wafer 200 with a minimum degree ofconvexity as shown in FIG. 3. A user of the ostomy wafer 200 may depressthe ring 100 into the adjustable layer 220 to obtain a medium degree ofconvexity, as shown in FIG. 4. The user may then further depress theinsert ring 100 to obtain a higher degree of convexity, as shown inFIGS. 5 and 6.

Provided herein are ostomy wafers 200 that comprise an adjustable layer220, wherein the adjustable layer 220 is a mouldable adjustable layer.In some instances, the mouldable adjustable layers 220 disclosed hereinare entirely mouldable. In some instances, the mouldable adjustablelayers 220 disclosed herein are partially mouldable. In some instances,the mouldable adjustable layer 220 is mouldable in a region proximal tothe effluent opening 223, but not at the outer edge of the mouldableadjustable layer 220. The mouldable adjustable layers 220 disclosedherein may comprise a three dimensional mouldable technology which, dueto its ability to conform to the stoma and surrounding skin, increasespatient comfort, peace of mind and quality of life. The mouldableadjustable layer 220 can be manipulated and molded by the insert rings100 disclosed herein and/or a user's finger(s). The mouldable adjustablelayers 220 disclosed herein may be adjusted to fit a variety ofstomaeristomal skin shapes, conditions and sizes. The ostomy wafers 200disclosed herein aim to provide a better fit for ostomates, molding notsimply to the stoma, but also molding to irregular skin contours andfolds.

Provided herein are adjustable ostomy wafers systems 90 that comprise: amouldable adjustable layer 220 and an insert ring 100 positioned insidethe mouldable adjustable layer 220, wherein the mouldable adjustablelayer 220 and the insert ring 100 comprise openings through whicheffluent flows. In some embodiments, the wafer 200 comprises an externallayer 230 having an adhesive body-contacting side 239. The inner regionof the external adhesive layer body-facing side 239 may at leastpartially overlap with the mouldable adjustable layer 220 to connectthese two layers and form a base 202 (of the adjustable wafer). Theinner circumference of the external layer 230 may be rigid and formed toengage a groove 120 of an insert ring 100. The insert ring 100, shown inFIG. 1 and FIG. 7, may be provided with the adjustable wafer 200, forexample in a kit or system 90. FIG. 2 depicts the external layer 230 onthe non-body-facing side 208 of the adjustable wafer 200. The insertring 100 is visible from the non-body-facing side 208 where it isaccessible to the ostomate or caregiver. FIG. 3 depicts the body-facingside 209 of the adjustable wafer 200 and the mouldable adjustable layer220. Release liners 232 in FIG. 3 are in place before use shielding theadhesive of the external layer 230 until use.

The convexity and mouldability of ostomy wafers 200 disclosed herein mayprovide an effective barrier that molds to a stoma and to irregular skincontours and folds. The ostomy wafers 200 disclosed herein are designedto adapt to the stoma, providing an improved seal against effluent onthe skin, and minimizing skin irritation and breakdown. Minimizing therisk of leakage helps an ostomy patient feel more confident in his orher ability to manage his or her stoma. As compared to current devices,the ostomy wafers 200 provided in the present application reduce therisk of leakages, reduce the risk of consequent infections, and reduceuser distress and discomfort.

The ostomy wafers 200 disclosed herein generally provide a primaryinterface seal that contacts the base of the ileum or perimeter of thestoma, to lessen the likelihood of effluent seeping underneath skinbarriers of the adjustable wafers 200 disclosed herein. In someinstances, the adjustable layer 220 forms the primary interface seal. Insome instances, the internal layer 210 forms the primary interface seal.In some instances, the adjustable layer 220 and the internal layer 210together form the primary interface seal. In some instances, anadditional layer forms the primary interface seal. In some instances,the ostomy wafers 200 disclosed herein, or at least one layer thereof,may be molded to conform to the surrounding peristomal skin, improvingthe seal. In some embodiments, the ostomy wafers 200 disclosed hereinmay have an adhesive sealed design, conferring flexibility andmalleability in order to adapt to the external environment of the stoma.The ostomy wafers 200 disclosed herein may be mouldable to stomas,without needing physical modification (e.g., cutting, tearing) toachieve an appropriate and effective fit. As a result, the user is moreconfident in the ostomy wafers 200 of the present application, lesslikely to experience embarrassing leakage, less likely to developinfection, and less likely to experience leakage-related skin damage, ascompared to use with current ostomy wafers.

The application of ostomy skin barrier products can be a time consumingprocess for many patients. As a result of the ostomy wafers 200disclosed herein being adaptable to each individual, the applicationtime is minimized. In some embodiments, the ostomy wafers 200 disclosedherein have the potential to eliminate the need for sealing accessoriessuch as paste and adhesive gaskets which can be costly, time-consuming,and messy. Easier application means its use will be easier to teach fornurses and easier to learn for patients. The ostomy wafers 200 disclosedherein are described for use with a gastrointestinal stoma, but could beused in other contexts as well where a convex shape or form is needed.

While the ostomy wafers 200 disclosed herein are especially advantageousfor the management of flush or retracted stomas, the ostomy wafers 200disclosed herein may be used for protruding stomas as well. For example,the protruding stoma may be buried between skin folds or buried in askin crease, thereby creating an effective recessed or retracted stoma.Generally, a protruding stoma is characterized by internal tissue (e.g.,ileum) protruding from a surgical opening beyond the surface ofsurrounding external skin. A flush stoma may be described as havingprotruding internal tissue, but the protruding tissue is surrounded byskin such that the distal end of the protruding internal tissue is flushwith or surrounding external and/or peristomal skin. Thus, theprotruding tissue does not extend beyond the surface of the surroundingskin. A retracted stoma may be characterized by an absence of protrudinginternal tissue. In the case of a retracted stoma, the internal tissuedoes not protrude beyond the perimeter of the stoma or the skinsurrounding the stoma. One of the benefits of the ostomy wafers 200disclosed herein is the ability to fit a range of stoma environments andtopographies, thereby eliminating the need for ostomates to purchasedifferent products as their stoma environment changes.

In the case of a flush stoma, the ostomy wafers 200 disclosed herein canbe pressed into or against the stoma resulting in the effluent openingof the adjustable layer 220 surrounding the internal tissue, with theperistomal skin at least partially surrounding and/or burying theadjustable layer 220. In the case of a retracted stoma, the adjustablelayer 220 may be pressed into or against the stoma to be at leastpartially surrounded by or buried in the peristomal skin without theopening of the adjustable layer 220 surrounding any internal tissue. Insome cases, the insert ring 100 is pressed against or in to theadjustable layer 220 before the ostomy wafer is applied to the stoma. Insome instances, the insert ring 100 is further pressed against or in tothe adjustable layer 220 after the ostomy wafer is applied to the stoma.In some cases, the insert ring 100 is pressed against or in to theadjustable layer 220 before the ostomy wafer 200 is applied to thestoma. In order to press the insert ring 100 against or in to theadjustable layer 220 after the ostomy wafer 200 is applied to the stoma,the ostomy wafer 200 may have a hole, ridge, or ring for the user'sfingers to engage and to apply a counter pressure to the pressure beingapplied on the insert ring 100.

Provided herein are adjustable ostomy wafer systems 90 wherein theinsert rings 100 are used with novel or existing ostomy wafers that havebeen designed or modified to engage the insert rings 100 disclosedherein. The ostomy wafers 200 disclosed herein may comprise a layer thatis initially flat, a flexible layer, a multi-layered laminate, a taperedthickness layer, or combinations thereof. However, the ostomy wafers 200disclosed herein generally have a layer or a portion thereof that isadjustable, stretchable, flexible or mouldable so that ostomy waferconvexity may be provided or increased by pressure with an insert ring100 disclosed herein. The ostomy wafers 200 disclosed herein generallyallow at least for minimal convexity (e.g., at least ⅛ inch). In certainembodiments, the ostomy wafers 200 disclosed herein additionally oralternatively provide a small degree of convexity (e.g., height ofactuated ostomy wafer is ⅛ inch to ½ inch). In certain embodiments, theostomy wafers 200 disclosed herein additionally or alternatively providea large degree of convexity (e.g., height of actuated ostomy wafer is0.5 inches to 1.5 inches).

Users of ostomy devices often complain about the discomfort of convexproducts. However, a certain amount of rigidity may be necessary tocreate the seal at the base of retracted stomas. In some embodiments,the devices disclosed herein allow for increased comfort through a waferperimeter that is more flexible than that of standard wafers whilemaintaining the rigidity via the insert ring 100 nearest the base of thestoma where it is needed. In some embodiments, the flexibility of thewafer 200 may decrease from the outer perimeter of the wafer towards theopening of the wafer. In some embodiments, the convexity (e.g., depth)is limited by the extensibility of the adjustable layer 220. Forexample, the adjustable layer may comprise a laminated adhesive.Durahesive Trilaminate is limited to about a depth of 0.5 inches.Varying convexities of the wafers are disclosed herein.

In some embodiments, the ostomy wafers 200 disclosed herein have thepotential to eliminate the need for sealing accessories such as pasteand seals. In some embodiments, sealing accessories are used with theostomy wafers 200 disclosed herein.

Insert Ring

Provided herein are ostomy wafer systems and kits that comprise insertrings 100 disclosed herein. The insert rings 100 are used in conjunctionwith adjustable layers 220 of ostomy wafers 200 disclosed herein toprovide varying levels of convexity to the ostomy wafers 200. The ostomywafer 200 with insert ring 100 may be provided to the ostomateseparately. The ostomy wafer system 90 may be provided to the ostomatewherein the ostomy wafer 200 and the insert ring 100 are provided to theostomate already engaged in an unactuated conformation with minimalconvexity, for example as seen in FIGS. 2 and 3. If more convexity isneeded, then the user would simply depress the insert ring 100 deeperinto the adjustable layer 220, stretching, extending, deepening ormoulding the adjustable layer 220 to the desired level. For example,when more convexity is desired, a device user may depress the insertring 100 into a mouldable adjustable layer 220 disclosed herein,deepening the mouldable adjustable layer 220 to a medium convexity, asshown in FIG. 4, or maximal (fully actuated) convexity, as shown inFIGS. 5 and 6.

The insert rings 100 disclosed herein may take on many shapes. Anon-limiting example of a cylindrical insert ring 100 is depicted inFIG. 1 with a diameter 102 and a height 104 perpendicular to thediameter 102. However, the insert rings 100 disclosed herein may becone-shaped, funnel-shaped, or tapered. In other words, the diameter 102may vary along the height 104 of the insert ring 100. In someembodiments, an opening of the insert ring 100 is circular. In someembodiments, an opening of the insert ring 100 is elliptical. In someembodiments, an opening of the insert ring 100 is irregular. In someembodiments, the end of the insert ring 100 that is in direct contactwith the user's fingers (not in direct contact with the adjustable layer220), comprises a lip, edge, or tab for assisting in the application ofthe insert ring 100. In this way, insert rings 100 of various shapes mayallow for the insert rings 100 to accommodate different stoma shapes andsizes, while reducing device bulk and/or increasing ease of manipulatingthe ring 100. The latter would be especially advantageous for thoseusers with reduced dexterity.

The insert ring 100 may be defined by an annular wall 110 with an innersurface 112 and an outer surface 114. The insert ring wall 110 may havea uniform thickness 116. The insert ring wall 110 may have varyingthickness 116. In certain embodiments, at least one portion of the wall110 may have a thickness 116 of about 0.1 cm. In certain embodiments, atleast one portion of the wall 110 may have a thickness 116 of about 0.2cm. In certain embodiments, at least one portion of the wall 110 mayhave a thickness 116 of about 0.3 cm. In certain embodiments, at leastone portion of the wall 110 may have a thickness 116 of about 0.4 cm. Incertain embodiments, at least one portion of the wall 110 may have athickness 116 of about 0.5 cm. In some embodiments, the wall 110 of theinsert ring 100 at the end of the insert ring 100 that is in directcontact with the user's fingers is thicker in order to receive pressurefrom fingers without fingers slipping off the ring 100. The latter wouldbe especially advantageous for those users with reduced dexterity orpoor eyesight.

The insert rings 100 disclosed herein may function as a singlestructural element. For instance, no additional parts, structures,components, or tools are necessary to employ the insert ring 100. Noadditional parts, structures, components, or tools are necessary toincrease the convexity of the adjustable layer other than the user'sfingers and the insert ring 100 itself.

The insert ring 100 may have a diameter 102 of about 2 cm to about 5 cm.The insert ring 100 may have a diameter 102 of about 2 cm to about 4.5cm. The insert ring 100 may have a diameter 102 of about 2 cm to about 4cm. The insert ring 100 may have a diameter 102 of about 2 cm to about3.5 cm. The insert ring 100 may have a diameter 102 of about 2 cm toabout 3 cm.

The insert ring 100 may have a height 104 (perpendicular to the diameter102 of the insert ring 100) between about 1 cm and about 5 cm. Theinsert ring 100 may have a height 104 between about 1 cm and about 4.5cm. The insert ring 100 may have a height 104 between about 1 cm andabout 4 cm. The insert ring 100 may have a height 104 between about 1 cmand about 3.5 cm. The insert ring 100 may have a height 104 betweenabout 1 cm and about 3 cm. The insert ring 100 may have a height 104between about 1 cm and about 2.5 cm. The insert ring 100 may have aheight 104 between about 1 cm and about 2 cm.

The insert ring 100 may comprise a ceramic material. The insert ring 100may comprise a metal. The insert ring 100 may comprise a hard plastic.The insert ring 100 may consist essentially of a ceramic material. Theinsert ring 100 may consist essentially of a metal. The insert ring 100may consist essentially of a hard plastic. The insert ring 100 mayconsist of a ceramic material. The insert ring 100 may consist of ametal. The insert ring 100 may consist of a hard plastic. The insertring 100 may comprise or consist of any material that provides theinsert ring 100 with a rigidity sufficient to receive force from a userand transfer that force into increasing the convexity of the adjustablelayer 220.

In some embodiments, the shape of the base 202 of the wafer 200 may helpto prevent the insert ring 100 from being pushed back as the innerdiameter of the adjustable layer 220 would tend to decrease when forceis applied to the insert ring 100 to form the convex shape. In someembodiments, the wafer 200 is a minimal convex adjustable wafer. In someembodiments, the wafer 200 is a medium convex adjustable wafer. In someembodiments, the wafer 200 is a maximal convex adjustable wafer. Theshape of the wafer 200 would prevent retraction as it would cause theinner diameter to decrease when force is applied to the insert ring 100from the adhesive side.

The insert ring 100 may have a groove 120. The insert ring 100 may havea plurality of grooves 120 as shown in FIG. 1. The ostomy wafer 200 mayhave convex insert 250 as shown in FIG. 7 that allows a groove 120 ofthe insert ring 100 to be set (temporarily or permanently) into aposition. The insert ring 100 with a plurality of grooves 120 may allowfor setting or locking the ring 100 into varying positions (e.g., anextended position), maintaining varying depths of convexity, as needed.Additionally or alternatively, the insert ring 100 may have grooves 120that engage a rigid structure present at the inner circumference of theexternal layer, adjustable layer or combination thereof. Alternativelyor additionally, the insert ring 100 may have a rigid structure orlocking tab that engages one or more grooves of the adjustable wafer200. A first groove 120 and a second groove 120 may be spaced by adistance of about 0.2 cm to about 1 cm. The first groove 120 and thesecond groove 120 may be spaced by a distance of about 0.2 cm to about0.8 cm. The first groove 120 and the second groove 120 may be spaced bya distance of about 0.2 cm to about 0.5 cm. The first groove 120 and thesecond groove 120 may be spaced by a distance of about 0.2 cm to about0.4 cm. The first groove 120 and the second groove 120 may be spaced bya distance of about 0.3 cm to about 0.5 cm.

In the case of a flush stoma, the insert ring 100 may be pressed into oragainst the stoma so that the internal tissue passes through the opening223 of the adjustable layer 220, resulting in the adjustable wafer 200surrounding the internal tissue, and peristomal skin at least partiallysurrounding/burying the adjustable wafer 200. In the case of a retractedstoma, the insert ring 100 may be pressed into the adjustable layer 220so that the adjustable wafer 200 is at least partially surrounded by orburied in the peristomal skin without surrounding any internal tissue,or without the opening 223 surrounding any internal tissue.

In some embodiments, the insert ring 100 provides a depth to a convexspace 226 of the adjustable layer 220. The depth of the convex space 226may be about 0.5 cm to about 5 cm. The depth of the convex space 226 maybe about 0.5 cm to about 4 cm. The depth of the convex space 226 may beabout 0.5 cm to about 3 cm. The depth of the convex space 226 may beabout 1 cm to about 5 cm. The depth of the convex space 226 may be about1.5 cm to about 5 cm. The depth of the convex space 226 may be about 2cm to about 5 cm. The depth of the convex space 226 may be about 2.5 cmto about 5 cm.

In some embodiments, the insert ring 100 has an inner diameter 102 tocover stoma openings that have a diameter of about a half inch to abouttwo inches. In some embodiments, the opening of the insert ring 100 iscircular. In some embodiments, the opening of the insert ring 100 isirregular. In some embodiments, the opening of the insert ring 100 isoval. In some embodiments, the insert ring 100 is adapted for a largerstoma, which may benefit from oval shape convexity.

Locking Tabs and Convex Inserts

Provided herein are devices, systems, and kits that comprise anadjustable ostomy wafer 200 and an insert ring 100, wherein theadjustable ostomy wafer 200 comprises a ring-engaging structure thatengages the insert ring 100, holding the insert ring 100 in place. Thering-engaging structure generally engages a groove 120 of the insertring 100. In some instances, the ring-engaging structure is providedseparately from the adjustable ostomy wafer. In some instances, thering-engaging structure is attached, connected or an integral part ofthe adjustable ostomy wafer 200. The ring-engaging structure may be arim or ridge located around the circumference of the effluent opening223, with a rigidity that is greater than the adjustable layer 220. Thering-engaging structure may be a convex insert 250. A cut-away view ofan exemplary convex insert 250 is shown in FIG. 7. In some instances,the convex insert 250 forms an entire ring. In some instances, theconvex insert 250 is only present in regions around the wafer 200. Insome instances, the convex insert 250 comprises a single ridge to engagethe groove(s) 120 of the insert ring 100. In some instances, the convexinsert 250 has multiple ridges to engage the groove(s) 120 of the insertring 100.

In some instances the convex insert 250 provides one or more ridgescomplementary to the groove(s) 120 of the insert ring 100, such that theinsert ring 100 may be screwed into or twisted into the convex insert250. Conversely, if the ostomate decides he or she would like todecrease the convexity once the ostomy wafer 200 is applied, theostomate may unscrew or untwist the insert ring 100, thereby retractingthe insert ring 100 and decreasing convexity of the adjustable ostomywafer 200.

In some instances, the ring-engaging structure is a locking tab 252 toengage the insert ring 100. In some instances, the adjustable ostomywafer 200 comprises a plurality of locking tabs 252. The locking tab 252may be permanently connected to the adjustable wafer 200 (e.g., cannotbe removed without damage to the wafer). The locking tab 252 may beseparate from the wafer 200, but capable of being connected to the wafer200. The locking tab 252 may be connected, either permanently ortemporarily, to the external layer 230. The locking tab 252 may beconnected, either permanently or temporarily, to the adjustable layer220. The locking tab 252 may be connected, either permanently ortemporarily, to the base of the wafer 200 formed by a combination of theexternal layer 230 and the adjustable layer 220. The locking tab 252 maybe connected, either permanently or temporarily, to the innercircumference of the external layer 230 or an inner region of theexternal layer 230 that is rigid and formed to engage a groove 120 of aninsert ring 100. The locking tab 252 may be connected, eitherpermanently or temporarily, to the inner circumference 203 of the waferbase 202 or an inner region of the wafer base 202 that is rigid andformed to engage a groove 120 of an insert ring 100.

The locking tab 252 may have any appropriate shape and size for engagingthe insert ring 100. The locking tab 252 may be inflexible, rigid orhard. The locking tab 252 may be made of a material with a physicalproperty similar to hard plastic. The locking tab 252 may comprise amaterial with a physical property similar to hard plastic. The lockingtab 252 may be made of a hard plastic material. The locking tab 252 maycomprise a hard plastic material.

Adhesives

Disclosed herein are adjustable ostomy wafer systems to be used withostomy devices, methods and kits, wherein the adjustable ostomy wafersystems may comprise adhesives or uses thereof. The general term“adhesive,” also referred to as “adhesive agent,” as used herein, refersto layers, fabrics, strips, laminates, barriers, gels, pastes,hydrocolloids, and glues that may be used to promote adherence of theadjustable wafer system to the ostomate and/or promote a seal betweenthe adjustable wafer system and the ostomate, thereby preventingundesirable leakage of effluent. The adhesive may comprise a sealingsubstance that promotes a seal between the adjustable wafer system andthe stoma/ostomate, thereby preventing effluent leakage. The adjustablewafer systems disclosed herein generally comprise an adhesive. However,it is not necessary for the adjustable wafer systems to comprise anadhesive.

In certain embodiments, the adjustable wafers 200 disclosed hereincomprise a moldable adhesive. In certain embodiments, the adjustablewafers 200 disclosed herein comprise a swellable adhesive. In certainembodiments, the adjustable wafers 200 disclosed herein comprise anadhesive that swells when exposed to stomal output. In certainembodiments, the adjustable wafers 200 disclosed herein comprise anadhesive that when exposed to stomal output seals around the stoma. Incertain embodiments, the adhesive is hydrocolloid and/or silicone-based.In certain embodiments, the adhesive is Durahesive or Stomahesive. Incertain embodiments, the adjustable wafers 200 disclosed herein compriseDurahesive Trilaminate. In certain embodiments, a thicker layer ofDurahesive in the Trilaminate is used for the body contact layer. Incertain embodiments, the thicker layer of Durahesive in the Trilaminateprovides the seal at the base of the stoma. In certain embodiments, athinner layer of Durahesive in the Trilaminate provides the attachmentof the adhesive wafer 200 to the convex component. In certainembodiments, an inner film layer provides support to the portion of theadhesive at the inner diameter of the convex component. Without thisfilm the adhesive in this area may break up during use. In certainembodiments, the inner film helps to hold the adhesive together duringdeployment of the insert ring 100, while being extensible to facilitatethe deployment of the insert ring 100. In some embodiments, the insertring 100 can be used for other adhesive laminations, but these factorsmay need to be considered.

Alternatively, or additionally, kits and methods may comprise anadhesive (e.g., an adhesive paste), or use thereof, that can be appliedto the adjustable wafer system 200, effectively eliminating gaps betweenthe stoma and the adjustable wafer system 200. Adhesives may also beused to promote adherence of an ostomy pouch 310 to the adjustable wafersystem 90. The adhesives disclosed herein ideally provide adhesion for avariety of skin conditions, as well as provide security and comfort forthe patient. To ensure the skin barrier adheres well to moist/dry skin,hydrocolloids may be used. The adhesives, such as barriers, seals,strips, laminates or fabrics, may comprise a release liner that is to beremoved before use. In other instances, the adhesives may not beprovided with a release liner. Rather, the adhesive quality of theadhesive may be present only when the adhesive makes contact with aliquid, gel, effluent, skin, heat, or combinations thereof. Theadhesives may have an adhering, sealing, or molding quality that isactivated and/or promoted by heat, and/or contact with effluent. Suchadhesives are well known in the field of ostomy care.

The ostomy wafers 200 disclosed herein may comprise a 3D mouldabletechnology that can be used to further improve the fit between theadjustable ostomy wafer and stomas. For example, ConvaTec MouldableTechnology (CMT), which improves the fit between skin barriers andstomas, can be used in addition to the adjustable wafer systems 90disclosed herein. For example, Durahesive technology used in CMT helpsto protect the skin from caustic effluent. Durahesive uses the effluentas an advantage, swelling or “turtlenecking” when coming in contact withliquid effluent, thereby improving the seal around the stoma. Thisadaptability to expand and contract around the stoma means that thebarrier will remain snug and secure during wear time. Ensuring a goodseal around the stoma minimizes the risk of effluent leaking under theskin barrier; reducing this risk of leakage helps prevent thedevelopment of peristomal skin complications.

The adjustable wafer system disclosed herein and components thereof maycomprise an adhesive selected from various adhesives, including, but notlimited to Durahesive/film/Durahesive Trilaminate. The formulation ofthese adhesives may be altered to increase further the product's appeal(e.g. comfort, flexibility, size, breathability, etc.). To improve theelasticity of the adhesive, an addition of a material (e.g.,styrene-isoprene-styrene (SIS) rubber) could be added. Oils could alsobe added to enhance the pliability and tack.

The adhesives disclosed herein may comprise a mucoadhesive. Themucoadhesive may be particularly help for maintaining sufficientadhesion under wet conditions. The mucoadhesive of certain embodimentscomprises a polymer with functional groups that provide adhesion to skinand stoma. The functional groups are selected from a group consisting ofthiols, acids and their salts, iminothiolanes, thioalkylamidines,catechols, amino acids, dihydroxy substituted aromatic groups, andcombinations thereof. The polymer is a biocompatible polymer made fromnatural or synthetic polymer selected from a group consisting ofpolyacrylates, polyakylmethacrylates, polyphenylmethacrylate,polyanhydrides, styrenic block copolymers, polyamides, polyesters,polyvinyl ethers, polyvinyl esters, sulfonated polymers, polyolefins,silicones, polyvinylpyrrolidones, polyvinylacetate and its copolymers,polyvinyl alcohol, polyurethanes, polyethers, copolymers of maleicanhydride, polysaccharides, polypeptides, gelatin, alginates, gums,starch, chitosan, pectin, and combinations thereof. The mucoadhesive mayfurther contain other components such as hydrophobic polymers,hydrophilic polymers, amphiphilic polymers, tackifiers, resins,plasticizers, hydrocolloids, inorganic and organic particulate fillers,antioxidants, and combinations thereof.

The adhesives may comprise a pressure sensitive adhesive comprising oneor more amphiphilic copolymers of polydimethylsiloxane, wherein thecopolymer is prepared using a polydimethylsiloxane orpolymethylhydrogensiloxane macroinitiator and at least one reactivehydrophilic or amphiphilic monomer, oligomer, macromer and combinationsthereof. The reactive hydrophilic or amphiphilic monomer may be selectedfrom a group consisting of N-vinyl caprolactams, vinyl esters, vinylethers, unsaturated acids or anhydrides and their salts, acrylates,methacrylates, acrylamides, methacrylamides, N-alkyl acrylamides,cyanate esters, hydroxy-alkyl acrylamides, glycidyl esters, glycidylethers, allyl monomers, and combinations thereof.

Wafer Layers

Provided herein are ostomy devices and systems comprising wafersdisclosed herein. The ostomy wafers disclosed herein (e.g., the ostomywafer 200) may comprise multiple layers. These layers may include anexternal layer 230, an adjustable layer 220, and/or an internal layer210 disclosed herein. The layers may function as molds, adhesives,seals, or skin barriers.

The ostomy wafers 200 disclosed herein may comprise an external layer230, also referred to herein as an “external adhesive layer,” in someembodiments. The external layer 230 may be the outermost (most distal tothe ostomate) layer of the ostomy wafer 200. The external layer 230 maybe a layer that does not extend into the stoma or internally beyond thestoma when applied to the ostomate. In certain embodiments, the externallayer 230 may consist of a single layer. In certain embodiments, theexternal layer 230 may comprise a multilayer or multi-laminate materialor multiple layers of material. In certain embodiments, the externallayer 230 may comprise Trilam (SH/DH). The Trilam may comprise aStomahesive seal or a Durahesive seal. The external layer 230 may bedescribed as a collar or flange to the adjustable layer 220 of theostomy wafer.

The ostomy wafers 200 disclosed herein may comprise an adjustable layer220. The adjustable layer 220 may be made of a material that allows forits deformation relative to its initial shape. For example, theadjustable layer 220 may be flexible, stretchable, mouldable, orextendable. Unless specified otherwise, any one of the adjustable layers220 disclosed herein may be a mouldable adjustable layer. The mouldableadjustable layer 220 may be entirely mouldable or partially mouldable.At least a portion of the mouldable adjustable layers 220 disclosedherein are mouldable. The portion may be proximal to the effluentopening 212. The portion may be an area of the mouldable adjustablelayer 220 in contact with the stoma.

The adjustable layer 220 may comprise a skin barrier. The skin barriermay comprise a mouldable adhesive. The mouldable adhesive may beflexible or pliable. The skin barrier may be ring-shaped. The adjustablelayer 220 may comprise an adhesive. The adjustable layer 220 maycomprise a stoma adhesive that adheres the adjustable layer toflush/retracted skin of the flush/retracted stoma, thereby securingand/or sealing the adjustable wafer system 90 to the ostomate. Theadjustable layer 220 or skin barrier may comprise a stoma adhesive. Thestoma adhesive may provide a barrier or seal against effluent, ensuringeffluent flows only through the opening 223 of the adjustable layer 220.Preferably, the skin barrier is mouldable, breathable, and/ormoisture-absorbing. By way of non-limiting example, the skin barrier maybe selected as a Stomahesive Seal (ConvaTec) and/or a Brava MouldableRing (Coloplast). These skin barriers are designed to fill incavities/folds in the intact skin around the stoma, helping to protectthe underlying skin from contact with bodily fluids. These are typicallymade from pectin-based, hydrocolloid-type ingredients, althoughcomposition varies by brand.

The adjustable layer 220 may be described as relatively cylindrical,funnel-shaped or bowl-shaped, with a mouth/rim that is in contact withthe external layer 230. The opening 223 of the adjustable layer 220through which effluent flows is generally positioned at/near the base222 of the bowl, opposite the mouth/rim 224. The adjustable layer 220should have appropriate dimensions for positioning into, around oragainst a flush or retracted stoma. For instance, with regards to theflush stoma, the opening of the adjustable layer 220 would fit aroundthe internal tissue with the convex sides of the “bowl” contacting theperistomal skin that rises around or surrounds the internal tissue, andthe “rim” of the “bowl” would not extend or would minimally extendbeyond the surface of the surrounding skin. In the instance of aretracted stoma, the adjustable layer 220 would not necessarily have tobe especially deep, but ideally would be wide enough to leave little orno space between the peristomal skin and the rim or sides of the bowl(adjustable layer 220). Thus, the depth of the “bowl” (adjustable layer220) may be between about half of a centimeter and about tencentimeters. The width of the bowl (adjustable layer 220) may be betweenabout two centimeters and about ten centimeters. The mouldableadjustable layer 220, as well as additional components of the adjustablewafer systems 90 disclosed herein, may be manufactured by use ofcompression molds. Application of heat is also a possibility for moldingan adhesive layer or component of the ostomy wafers 200 disclosedherein.

Certain embodiments provided herein relate to wafer systems 90consisting essentially of an adjustable layer 220 disclosed herein andan insert ring 100 disclosed herein. The adjustable layer 220 mayconsist of a single layer. The single layer may be an adjustable layer220 disclosed herein. The adjustable layer 220 may comprise multiplematerials laminated together. The adjustable layer 220 may comprise amulti-laminate material. The adjustable layer 220 may comprise amaterial selected from Stomahesive seal.

The external adhesive layer 230 and the adjustable layer 220 aregenerally concentric, while the external adhesive layer 230 andadjustable layer 220 may at least partially overlap. Typically, theouter diameter of the external adhesive layer 230 is greater than theouter diameter of the adjustable layer 220. In some instances, theexternal adhesive layer 230 surrounds the adjustable layer 220circumferentially. In some instances, the external adhesive layer 230and the adjustable layer 220 may not necessarily overlap. In someinstances, the external adhesive layer 230 has a flat ring shape and theadjustable layer 220 has a three-dimensional ring shape during use.

The adjustable wafer 200 may comprise one or more additional layers. Theone or more additional layers may comprise, for example, an additionaladhesive layer. The one or more additional layers may also be concentricwith the adjustable layer 220. For example, ostomy wafers disclosedherein may comprise an external adhesive layer 230 concentricallysurrounding an adjustable layer 220, wherein the adjustable layer 220 issubstantially and directly surrounded by the external adhesive layer230. Alternatively, ostomy wafers 200 disclosed herein may comprise anexternal adhesive layer 230 concentrically surrounding an adjustablelayer 220, wherein the adjustable layer 220 is separated from theexternal adhesive layer 230 by an additional layer. The additional layermay comprise a barrier, seal or adhesive not provided by the adjustablelayer 220 that provides further protection against leakage. This wouldbe especially advantageous where the external adhesive layer 230 isprimarily designed to adhere to external skin, but not provide much of abarrier against effluent.

The adjustable wafers 200 disclosed herein may comprise an internallayer 210. The internal layer 210 may at least partially cover thebody-facing surface of the mouldable adjustable layer 220, and comprisesa stoma adhesive 212 on a stoma-facing side 209 of the internal layer210. The stoma adhesive 212 adheres the internal layer 210 toflush/retracted skin of the flush/retracted stoma, thereby additionallysecuring the adjustable wafer 200 to the ostomate. The internal layer210 may be positioned on the convex surface 222 of the adjustable layer220 so that the internal layer 210 contacts peristomal skin. Theinternal layer 210 may comprise Stomahesive seal. The internal layer 210may comprise Stomahesive paste.

The adjustable wafers systems 90 disclosed herein may comprise one ormore additional layers. The one or more additional layers may compriseat least one adhesive. The one or more additional layers may notnecessarily comprise adhesive. The one or more additional layers maycomprise a material selected from adhesive, laminate, foam, gel, rubber,fabric, plastic, and combinations thereof. The one or more additionallayers may contribute to the flexibility or mouldable character of thedisclosed adjustable wafer systems.

The adjustable wafer systems may further comprise a flange or collarattached to the external layer 230, wherein the flange or collarcomprises additional skin adhesive for further securing the adjustablewafer system 90 to the ostomate and/or sealing the adjustable wafersystems 90 to the ostomate, thereby preventing leakage. In addition,there are numerous methods for providing a successful fit and/or sealwhen applying a flange to the stoma; a common method is by applying anadhesive substance around the stoma. For instance, a paste is a highlyeffective sealant and protective skin barrier; the paste may be usedbetween the base of the ileum or perimeter of the stoma and the openingof the wafer/baseplate as filler for skin folds, uneven skin surfacesand scars. Another method is by using silicone gel to fill uneven skinsurfaces; once the gel is applied directly around the stoma the ostomatethen applies a wafer/baseplate directly onto the gel. The gel will thencure underneath the wafer/baseplate during normal wear time. Examples ofpastes and gel include, but are not limited to, ConvaTec's Stomahesivepaste.

The adjustable wafer systems 90 disclosed herein may further comprise acoupling component 260 that couples or adheres the adjustable wafersystem 90 to, for example, an ostomy pouch 310 or an ostomy cap. Thecoupling component 260 may be attached to the wafer 200, wherein thewafer 200 comprises an external layer 230 and an adjustable layer 220.The coupling component 260 may be an additional layer of the wafer 200.The coupling component 260 may mechanically connect the adjustable wafersystem 90 to the ostomy pouch. The coupling component 260 may connectthe adjustable wafer systems 90 disclosed herein to the ostomy pouch 310via an adhesive, the adhesive being provided by the ostomy pouch 310 orcomponent thereof, and/or by the coupling component or by an additionalproduct (e.g., glue, paste). Alternatively, the adjustable wafer systems90 disclosed herein may not necessarily comprise a coupling component260. Instead, the adjustable wafer systems 90 may contact the pouch 310directly or be integrated into an ostomy device 300 (such as a waferdirectly connected to an ostomy pouch, bag or cap) or may contact acoupling component on the pouch 310, bag, or cap.

Ostomy Devices

With additional reference to FIG. 8, further disclosed herein are ostomysystems or devices 300 that comprise an ostomy pouch 310, bag or cap andany one of the adjustable ostomy wafers 200 disclosed herein. The ostomydevice 300 may comprise one or more coupling components on the ostomypouch 310 and/or adjustable ostomy wafer 200 for connecting the ostomypouch 300 and adjustable ostomy wafer 200 in an operative state. Thecoupling component may comprise a limited motion connection between theadjustable wafer system 90 and the ostomy pouch 310 that permitsrelative displacement between (i) substantially the entire adjustablewafer system 90 and (ii) the entrance aperture of the ostomy pouch 310,the limited motion connection guiding said relative displacement along alimited motion locus, between (a) an operative position and an accessposition; and (b) a fixation coupling for fixing the adjustable wafersystems 90 disclosed herein and the ostomy pouch 310 when in theoperative position.

In certain embodiments, the devices 300 disclosed herein comprise two ormore separate pieces. In certain embodiments, the devices 300 disclosedherein comprise an ostomy wafer 200 disclosed herein and a pouch 310,wherein the ostomy wafer 200 and pouch 310 are separate. In certainembodiments, the devices 300 disclosed herein comprise an ostomy wafer200 and a pouch 310, wherein the ostomy wafer 200 and pouch 310 areseparable before and/or after use. In certain embodiments, the pouch 310and/or ostomy wafer 200 are referred to as a two-piece device. Incertain embodiments, the pouch 310 and/or ostomy wafer 200 are providedwith a coupling mechanism. In certain embodiments, the couplingmechanism is selected from a flange coupling and an adhesive coupling.In certain embodiments, the pouch 310 and the ostomy wafer 200 arepermanently connected. In certain embodiments, the device 300 isreferred to as a one-piece device or system. In certain embodiments, thepouch 310 and ostomy wafer 200 are permanently connected via an adhesivecomponent and/or a mechanical component. In certain embodiments, thepouch 310 and ostomy wafer 200 are not separated without damaging thepouch 310 and/or ostomy wafer 200.

In the operative position, the adjustable wafer system 90 is superposedaround the entrance aperture of the ostomy pouch 310, and an adaptableregion of the adjustable ostomy wafer 200 is shrouded by, for example,an ostomy pouch 310 on the non-body-facing side 208. The access positionprovides access to the adaptable region from the non-body-facing side208.

Such an arrangement can guide alignment of the adjustable ostomy wafer200 and the ostomy pouch 310 to the operative position, making suchalignment much easier for elderly, non-dexterous, or visually impairedpersons. At the same time, the limited motion coupling permits relativedisplacement of substantially the entire adjustable ostomy wafer 200with respect to the entrance aperture, allowing access for adapting theadjustable ostomy wafer 200 to the size and/or shape of the user'sstoma. The limited motion connection may comprise an articulating link,the articulation defining the locus of limited motion.

The ostomy device 300 may be a one-piece ostomy device to enhance accessto the adjustable wafer system 90, while avoiding problems of a whollyor partly immovable adjustable wafer system as in the prior art. Theadjustable wafer systems 90 disclosed herein may be permanently attachedto the ostomy pouch 310 directly, or permanently attached to thecoupling component, wherein the coupling component is permanentlyattached to the ostomy pouch 310. As used herein the term “permanentlyattached” (or like phrases) means that the pieces are attached sostrongly that they cannot be separated without breakage or damage thatprevents reattachment without additional equipment. The ability torelatively displace the entire adjustable wafer system 90 with respectto the entrance aperture of the ostomy pouch 310 may permit easieradaptation of the adjustable wafer system 90 (whether by forming,cutting or shaping the stomal aperture, or by fitting and/or shaping aseparate sealing member at the stomal aperture).

The ostomy device 300 disclosed herein may also be a two-piece ostomydevice to facilitate easier alignment of the components, withoutsignificantly reducing ease of access for adapting the adjustable wafersystem 90 to the size and/or shape of stoma, nor detracting from theability to position the body-fitment on the body before fixing theappliance in the operative position with respect to the body fitment.The limited motion connection and the coupling component may comprisereleasable coupling portions.

The adjustable wafer systems 90 disclosed herein may work well fortwo-piece and one-piece ostomy devices. The insert ring 100 may beactuated through the pouch film.

Methods of Use

Provided herein are methods of using the adjustable ostomy wafers andostomy devices disclosed herein. The methods may comprise providing orincreasing a convexity of an adjustable layer 220 to the adjustableostomy wafer 200. Providing or increasing the convexity may comprisepressing an insert ring 100 disclosed herein into or against theadjustable layer 220. Providing or increasing the convexity may comprisescrewing, twisting, or pushing an insert ring 100 disclosed herein intoor against the adjustable layer 220. The methods may comprise contactinga stoma of a subject with an adjustable ostomy wafer 200 disclosedherein, wherein a convexity of the adjustable ostomy wafer 200 has beenadjusted with an insert ring 100 disclosed herein. The methods maycomprise contacting a stoma of a subject with an adjustable ostomy wafer200 disclosed herein, and subsequently adjusting a convexity of anadjustable layer 220 of the wafer with an insert ring 100 disclosedherein. The methods disclosed herein may comprise retracting the insertring 100 from the adjustable layer 220 to decrease convexity. Retractingmay comprise pulling, twisting, or unscrewing an insert ring 100 fromthe adjustable ostomy wafer. Retracting may comprise disengaging agroove 120 of an insert ring 100 from the adjustable ostomy wafer 200 orportion thereof. Retracting may comprise disengaging a groove 120 of aninsert ring from a locking tab 252 disclosed herein.

The methods may further comprise contacting the adjustable ostomy wafer200 with an ostomy pouch 310 or plug that fills the opening(s) of theadjustable ostomy wafer 200. The methods may further comprise contactingthe flush/retracted stoma or the adjustable ostomy wafer 200 with anadhering substance that promotes adherence of the adjustable ostomywafer 200 to the ostomate. The methods may further comprise contactingthe flush/retracted stoma or the adjustable ostomy wafer 200 with anadditional adhesive besides the adhesive(s) that is a component of theadjustable ostomy wafer 200. The methods may comprise applying heat formolding the adjustable ostomy wafer 200 or promoting the adherentproperty of the additional adhesive.

Kits

With additional reference to FIG. 9, certain embodiments of the presentapplication relate to a kit 400 including a plurality of insert rings410 and an ostomy wafer 420. The insert rings 410 may be provided alongthe lines of the above-described insert ring 100, and may include afirst insert ring 100 and a second insert ring 100′. The ostomy wafer420 may be provided along the lines of the ostomy wafers 200 describedherein. In certain embodiments, a kit 400 comprises: an ostomy wafer420, 200 comprising an adjustable layer 220, with an effluent opening223 through which effluent flows; and a plurality of insert rings 410capable of providing or increasing convexity of the adjustable layer 220when the insert ring 100/100′ is pressed against the non-body-facingside 208 of the adjustable layer 220, wherein a first insert ring 100and a second insert ring 100′ of the plurality of insert rings 410differ in an aspect selected from diameter, rigidity, height, and acombination thereof. In some embodiments, at least one insert ring 100of the plurality of insert rings 410 comprises a groove 120 that engagesa portion of the adjustable layer 220. In some embodiments, the firstinsert ring 100 and the second insert ring 100′ each comprise at leastone groove 120. In some embodiments, the first insert ring 100 and thesecond insert ring 100′ comprise a different number of grooves 120.

The kit 400 may further comprise a kit component 430 selected from anostomy pouch (e.g., the above-described ostomy pouch 310), an adhesiveseal, an adhesive barrier, an adhesive strip, an adhesive fabric, anadhesive paste, and combinations thereof. The ostomy pouch 310 may becapable of coupling to a coupling component 260 of the ostomy wafer 200.

In some embodiments, the kit 400 comprises a plurality of insert rings410 wherein a first insert ring 100 has a first diameter 102 and asecond insert ring 100′ has a second diameter 102′. In some embodimentsthe first diameter 102 and the second diameter 102′ are the same. Insome embodiments, the first diameter 102 and the second diameter 102′are different. In some embodiments, the kit 400 comprises a singleinsert ring 100 with a plurality of peel away layers or a peel awaylayer with a guide so as to adjust the insert ring 100 to the size ofthe stoma opening. In some embodiments, the kit 400 comprises aplurality of insert rings 410 that are nested and removed as needed.

In some embodiments, the kit 400 comprises a plurality of insert rings410 wherein a first insert ring 100 has a first height 104 and a secondinsert ring 100 has a second height 104′. In some embodiments, the firstheight 104 and the second height 104′ are the same. In some embodiments,the first height 104 and the second height 104′ are different.

In some embodiments, the kits comprise a plurality of insert rings 410wherein a first opening of a first insert ring 100 has a first openingdiameter 102 and a second opening of a second insert ring 100′ has asecond opening diameter 102′. In some embodiments, the first openingdiameter 102 and the second opening diameter 102′ are the same. In someembodiments, the first opening diameter 102 and the second openingdiameter 102′ are different.

Examples Example 1: Application of an Adjustable Ostomy Wafer withAdjustable Convexity to a Retracted Stoma; Adjusting Convexity Prior toApplication

Hands and skin surrounding the stoma are clean, dry and free from anysolvent or oily substances before applying the ostomy system. Theadjustable wafer 200 has an external (adhesive) layer 230 with abody-facing side 209 outer region that adheres to skin around the stoma.The inner region of the external adhesive layer 230 body-facing side 209partially overlaps with an adjustable layer 220 to connect these twolayers 220, 230 and form the base (of the adjustable wafer). The innercircumference of the external layer 230 is rigid and formed to engage agroove 120 of an insert ring 100. The insert ring 100, shown in FIG. 1and FIG. 7 is provided with the adjustable wafer 200, for example in akit. FIG. 2 depicts the non-body-facing side 208 of the adjustable wafer200. The insert ring 100 is visible from the non-body-facing side 208where it is accessible to the ostomate or caregiver. FIG. 3 depicts thebody-facing side 209 of the adjustable wafer 200. Release liners 232 arein place before use shielding the adhesive of the external layer 230until use.

The insert ring 100 is depressed into the adjustable layer and into thestoma opening, increasing the convexity of the adjustable layer. Theuser must pull back on the base 202 with fingers while pushing theinsert ring 100 down with thumbs. The insert ring 100 is depressed intothe adjustable layer 220 to meet the depth of the stoma. The adjustablering 100 engages the inner circumference of the external layer 230,maintaining the convexity of the adjustable wafer 200. The user desiresmore convexity and depresses the insert ring 100 into the adjustablelayer 220 further, engaging the next groove 120 in the insert ring 100,thereby maintaining a higher degree of convexity for the adjustablewafer 200. Immediately before use, the release liners 232 are removed.The body-facing side 209 and opening of the adjustable layer 220 iscentered over the stoma. The adjustable wafer 200 is pressed against thestoma and surrounding skin. The external layer 230 adheres to skinsurrounding the stoma. By compressing the skin barrier around the stomathe adhesive molds around the stoma, providing an effective seal. Theadjustable layer 220, which is made of a material that constitutes askin barrier, is molded to the stoma opening shape and size, withoutneeding scissors to adapt the ostomy system. The skin barrier is appliedagainst the skin around the stoma for thirty seconds, allowing thebarrier to adapt or mold to the environment. Coverage and comfort aretested with ISO 8670-2 testing, Ink testing and/or Flex testing (e.g.Zwick U.T.M).

Example 2: Application of a Mouldable Wafer with Adjustable Convexity toa Refracted Stoma; Adjusting Convexity During and after Application

Hands and skin surrounding the stoma are clean, dry and free from anysolvent or oily substances before applying the ostomy system. Theadjustable wafer has an external (adhesive) layer 230 with a body-facingside 209 outer region that adheres to skin around the stoma. The innerregion of the external adhesive layer 230 body-facing side 209 partiallyoverlaps with an adjustable layer 220 to connect these two layers, 220,230 forming a wafer base 202. The inner circumference of the externallayer 230 or wafer base 202 is rigid and formed to engage a groove 120of an insert ring 100. The insert ring 100, shown in FIG. 1 and FIG. 7,is provided with the adjustable wafer 200, for example in a kit. FIG. 2depicts the non-body-facing side 208 of the adjustable wafer 200. Theinsert ring 100 is visible from the non-body-facing side 208 where it isaccessible to the ostomate or caregiver. FIG. 3 depicts the body-facingside 209 of the adjustable wafer 200. Release liners 232 are in placebefore use, thereby shielding the adhesive of the external layer 230until use. Immediately before use, the release liners 232 are removed.

The body-facing side 209 and opening 223 of the adjustable layer 220 iscentered over the stoma. The adjustable wafer 200 is pressed against thestoma and surrounding skin. The external layer 230 adheres to skinsurrounding the stoma. The insert ring 100 is depressed into theadjustable layer 220 and into the stoma opening, increasing theconvexity of the adjustable layer 220. The insert ring 100 is depressedinto the adjustable layer 220 to meet the depth of the stoma. Theadjustable ring 100 engages the inner circumference of the externallayer 230, maintaining the convexity of the adjustable wafer 200. Theuser desires more convexity and depresses the insert ring 100 into theadjustable layer 220 further, engaging the next groove 120 in the insertring 100, thereby maintaining a higher degree of convexity for theadjustable wafer 200. The adjustable layer 220, which is made of amaterial that constitutes a skin barrier, is molded to the stoma openingshape and size, without needing scissors to adapt the ostomy system. Theskin barrier is applied against the skin around the stoma for thirtyseconds, allowing the barrier to adapt/mold to the environment. Coverageand comfort are tested with ISO 8670-2 testing, Ink testing and/or Flextesting (e.g. Zwick U.T.M).

Example 3—Application of a Mouldable Wafer with Adjustable Convexity toa Refracted Stoma; Adjusting and Maintaining Convexity withoutEngagement of Adjustable Ring Insert Grooves

Hands and skin surrounding the stoma are clean, dry and free from anysolvent or oily substances before applying the ostomy system 90. Theadjustable wafer 200 has an external (adhesive) layer 230 with abody-facing side 209 outer region that adheres to skin around the stoma.The inner region of the external adhesive layer 230 body-facing side 209partially overlaps with an adjustable layer 220 to connect these twolayers. The insert ring 100, shown in FIG. 1 and FIG. 7, is providedwith the adjustable wafer 200, for example in a kit. FIG. 2 depicts thenon-body-facing side 208 of the adjustable wafer 200. The insert ring100 is visible from the non-body-facing side 208, where it is accessibleto the ostomate or caregiver. FIG. 3 depicts the body-facing side 209 ofthe adjustable wafer 200. Release liners 232 are in place before useshielding the adhesive of the external layer 230 until use. Immediatelybefore use, the release liners 232 are removed.

The body-facing side 209 and opening of the adjustable layer 220 iscentered over the stoma. The adjustable wafer 200 is pressed against thestoma and surrounding skin. The external layer 230 adheres to skinsurrounding the stoma. The insert ring 100 is depressed into theadjustable layer 220 and into the stoma opening, increasing theconvexity of the adjustable layer 220. The insert ring 100 is depressedinto the adjustable layer to meet the depth of the stoma. Once thedesired depth is met, the insert ring 100 is removed and the adjustablelayer 220 maintains its convexity due to the nature of the material ofwhich the adjustable layer 220 is formed. Alternatively, the insert ring100 remains depressed into the adjustable layer 220. The adjustablelayer 220, which is made of a material that constitutes a skin barrier,is molded to the stoma opening shape and size, without needing scissorsto adapt the ostomy system 90. The skin barrier is applied against theskin around the stoma for thirty seconds, allowing the barrier toadapt/mold to the environment. Coverage and comfort are tested with ISO8670-2 testing, Ink testing and/or Flex testing (e.g., Zwick U.T.M).

Certain embodiments of the present application relate to an adjustableostomy wafer system comprising: a. an ostomy wafer comprising anadjustable layer, with an effluent opening through which effluent flows;and b. an insert ring capable of providing or increasing convexity ofthe adjustable layer when the insert ring is pressed against thenon-body-facing side of the adjustable layer.

In certain embodiments, the adjustable ostomy wafer system furthercomprises an external adhesive layer extending beyond an outer edge ofthe adjustable layer, wherein the external adhesive layer has anadhesive body-facing side.

In certain embodiments, the adjustable layer holds the insert ring inplace during use to maintain the convexity in the adjustable layer.

In certain embodiments, the insert ring comprises a groove that engagesa portion of the adjustable layer.

In certain embodiments, the groove engages an edge of the adjustablelayer located proximal to the effluent opening, thereby securing andmaintaining a position of the insert ring in the adjustable layer.

In certain embodiments, the adjustable ostomy wafer system furthercomprises a convex insert, wherein the groove engages the convex insert,thereby securing and maintaining a position of the insert ring in theadjustable layer.

In certain embodiments, at least a portion of the convex insert thatengages the groove is more rigid than the adjustable layer or a portionthereof.

In certain embodiments, the adjustable ostomy wafer system furthercomprises at least one locking tab that engages the groove of the insertring, maintaining a position of the insert ring in the adjustable layer.

In certain embodiments, the insert ring comprises a plurality ofgrooves, wherein each of the grooves corresponds to a different level ofconvexity of the adjustable layer.

In certain embodiments, the convexity of the adjustable layer is variedbetween a minimal convexity of about ⅛ inch and a maximal convexity ofabout 1 inch.

In certain embodiments, the convexity of the adjustable layer is variedbetween a minimal convexity of about ½ inch and a maximal convexity ofabout 1 inch.

In certain embodiments, the adjustable ostomy wafer system furthercomprises an internal adhesive layer that at least partially covers thebody-facing surface of the adjustable layer.

In certain embodiments, the adjustable layer comprises an adhesiveagent.

In certain embodiments, the adjustable layer provides a barrier or sealagainst effluent, ensuring effluent flows only through the effluentopening.

In certain embodiments, the height of the insert ring may be modulatedby the user.

In certain embodiments, the insert ring is flexible.

In certain embodiments, the insert ring is rigid.

In certain embodiments, the adjustable ostomy wafer system furthercomprises a coupling component that couples the ostomy wafer to anostomy pouch.

In certain embodiments, the coupling component mechanically couples theostomy wafer to the ostomy pouch.

In certain embodiments, the coupling component adhesively couples theostomy wafer to the ostomy pouch.

In certain embodiments, the coupling component can be attached to theostomy pouch and subsequently separated without damage to the ostomypouch or the coupling component.

Certain embodiments relate to an ostomy device comprising the adjustableostomy wafer system and an ostomy pouch.

In certain embodiments, the ostomy wafer is permanently attached to theostomy pouch.

In certain embodiments, the ostomy wafer and ostomy pouch are configuredsuch that the effluent opening is not sealed to an ostomy pouch openinguntil after the insert ring is pressed against the non-body-facing sideof the adjustable layer and the ostomy wafer is applied to the stoma.

In certain embodiments, the ostomy wafer and ostomy pouch are providedas separate pieces before use.

Certain embodiments relate to a method of using the adjustable ostomywafer system or the ostomy device, the method comprising contacting aflush stoma or a retracted stoma with the ostomy wafer.

In certain embodiments, the method further comprises pressing the insertring into the adjustable layer to provide or increase convexity of theadjustable layer.

In certain embodiments, the method further comprises retracting theinsert ring from the adjustable layer after pressing to decreaseconvexity.

Certain embodiments of the present application relate to a kitcomprising: a. an ostomy wafer comprising an adjustable layer, with aneffluent opening through which effluent flows; and b. a plurality ofinsert rings capable of providing or increasing convexity of theadjustable layer when the insert ring is pressed against thenon-body-facing side of the adjustable layer, wherein a first insertring and a second insert ring of the plurality of insert rings differ inan aspect selected from diameter, rigidity, height, and a combinationthereof.

In certain embodiments, at least one insert ring comprises a groove thatengages a portion of the adjustable layer.

In certain embodiments, the first insert ring and the second insert ringeach comprise at least one groove.

In certain embodiments, the first insert ring and the second insert ringcomprise a different number of grooves.

In certain embodiments, the kit further comprises an ostomy pouch,wherein the ostomy pouch is capable of coupling to a coupling componentof the ostomy wafer.

In certain embodiments, the ostomy pouch and the ostomy wafer areprovided as separate components before use.

In certain embodiments, the ostomy pouch and the ostomy wafer areconnected before use, but the effluent opening and non-body-facing sideof the ostomy wafer is exposed before use.

What is claimed is:
 1. An adjustable ostomy wafer system comprising: a.an ostomy wafer comprising an adjustable layer, with an effluent openingthrough which effluent flows, wherein the adjustable layer has abody-facing side and a non-body-facing side; and b. an insert ringcapable of providing or increasing convexity of the adjustable layerwhen the insert ring is pressed against the non-body-facing side of theadjustable layer.
 2. The adjustable ostomy wafer system of claim 1,further comprising an external adhesive layer extending beyond an outeredge of the adjustable layer, wherein the external adhesive layer has anadhesive body-facing side.
 3. The adjustable ostomy wafer system ofclaim 1, wherein the adjustable layer holds the insert ring in placeduring use to maintain the convexity in the adjustable layer.
 4. Theadjustable ostomy wafer system of claim 1, wherein the insert ringcomprises a groove that engages a portion of the adjustable layer. 5.The adjustable ostomy wafer system of claim 4, wherein the grooveengages an edge of the adjustable layer located proximal to the effluentopening, thereby securing and maintaining a position of the insert ringin the adjustable layer.
 6. The adjustable ostomy wafer system of claim4, further comprising a convex insert, wherein the groove engages theconvex insert, thereby securing and maintaining a position of the insertring in the adjustable layer.
 7. The adjustable ostomy wafer system ofclaim 6, wherein at least a portion of the convex insert that engagesthe groove is more rigid than the adjustable layer or a portion thereof.8. The adjustable ostomy wafer system of claim 4, further comprising atleast one locking tab that engages the groove of the insert ring,thereby maintaining a position of the insert ring in the adjustablelayer.
 9. The adjustable ostomy wafer system of claim 4, wherein theinsert ring comprises a plurality of grooves, and wherein each of thegrooves corresponds to a different level of convexity of the adjustablelayer.
 10. The adjustable ostomy wafer system of claim 1, wherein theconvexity of the adjustable layer is variable between a minimalconvexity and a maximal convexity, and wherein the maximal convexity isabout one inch.
 11. The adjustable ostomy wafer system of claim 1,further comprising an internal adhesive layer that at least partiallycovers the body-facing surface of the adjustable layer.
 12. Theadjustable ostomy wafer system of claim 1, wherein the adjustable layerprovides a barrier or seal against effluent, thereby ensuring effluentflows only through the effluent opening.
 13. A method of using theadjustable ostomy wafer system of claim 1, the method comprisingcontacting a flush stoma or a retracted stoma with the ostomy wafer 14.A kit comprising: a. an ostomy wafer comprising an adjustable layer,with an effluent opening through which effluent flows, wherein theadjustable layer has a body-facing side and a non-body-facing side; andb. a plurality of insert rings capable of providing or increasingconvexity of the adjustable layer when the insert ring is pressedagainst the non-body-facing side of the adjustable layer, wherein afirst insert ring and a second insert ring of the plurality of insertrings differ in an aspect selected from diameter, rigidity, height, anda combination thereof.
 15. The kit of claim 14, wherein at least oneinsert ring comprises a groove that engages a portion of the adjustablelayer.
 16. The kit of claim 15, wherein the first insert ring and thesecond insert ring each comprise at least one groove.
 17. The kit ofclaim 16, wherein the first insert ring and the second insert ringcomprise a different number of grooves.
 18. The kit of claim 14, furthercomprising an ostomy pouch, wherein the ostomy pouch is capable ofcoupling to a coupling component of the ostomy wafer.
 19. The kit ofclaim 18, wherein the ostomy pouch and the ostomy wafer are provided asseparate components before use.
 20. The kit of claim 19, wherein theostomy pouch and the ostomy wafer are connected before use, but theeffluent opening and non-body-facing side of the ostomy wafer is exposedbefore use.